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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaners, Medical Devices
510(k) Number K920406
Device Name DECOMAT 228
Applicant
Getinge International, Inc.
1100 Towbin Ave.
Lakewood,  NJ  08701
Applicant Contact PAUL RODRIGUEZ
Correspondent
Getinge International, Inc.
1100 Towbin Ave.
Lakewood,  NJ  08701
Correspondent Contact PAUL RODRIGUEZ
Regulation Number880.6992
Classification Product Code
MDZ  
Date Received01/31/1992
Decision Date 04/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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